Effect of Colchicine on Coronary Reperfusion in Patients With Acute Coronary Syndrome

NCT05472337 | Recruiting Phase 2 DMC

• 1 other identifier: 210507002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial will determine the treatment effect of colchicine (1.5 mg loading dose and 0.5 mg daily thereafter) for 6 weeks on microvascular coronary reperfusion and infarct size in patients with acute coronary syndrome.

Conditions

Acute Coronary Syndrome

Keywords

Colchicine; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Acute Coronary Syndrome; Myocardial Reperfusion; Anti-Inflammatory Agents

Outcome Measures

Primary Outcomes (1)

• Change in Index of Microcirculatory resistance (IMR) between pre and post-coronary angioplasty.

  Invasive assessment of Index of Microvascular Resistance (IMR) before and after angioplasty in both colchicine and control group.

  baseline ( pre-angioplasty) and at the end of the procedure (angioplasty)

Secondary Outcomes (4)

• Average value of endpoint IMR.

  at the end of the procedure (angioplasty)

• Change in cardiac enzyme levels (troponin) before and after angioplasty in both colchicine and control group.

  baseline (pre-angioplasty) and 24 h post-angioplasty

• Change in level of inflammatory markers ( Ultra-sensible C-reactive protein and IL-6) at baseline and 6 week follow-up.

  baseline (prior to Colchicine administration) and at 6 weeks after discharge

• Percent of salvaged myocardium.

  baseline (two - four days post-angioplasty and at 6 weeks after discharge

Study Arms (2)

Colchicine

EXPERIMENTAL

Subjects allocated to the intervention group will receive colchicine + standard of care for 6 weeks.

Drug: Colchicine

Standard of Care - Control

NO INTERVENTION

Subjects allocated to the control group will receive only standard of care for 6 weeks.

Interventions

Colchicine DRUG

Oral colchicine (1 mg loading dose followed by 0.5 mg 1 hour later, administered 6 to 24 hours before angioplasty, followed by 0.5 mg (1 comp.) per day for 6 weeks.

Colchicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years.
• Adults hospitalized at the Clinical Hospital of the Catholic University for an ACS condition, defined as:
• \- Presence of chest pain, associated with enzymatic elevation (increase of ultrasensitive troponin above normal value (99th percentile)) with or without electrocardiographic changes.
• Patients undergoing coronary angiography with the intention of angioplasty in the next few days (during the index hospitalization).
• Ability and willingness to provide written informed consent.

You may not qualify if:

• ST-segment elevation myocardial infarction (undergoing emergency angioplasty therefore not allowing time for the administration and effect of colchicine).
• Severe left main stenosis.
• Advanced heart failure, left ventricular ejection fraction \<35%.
• Related to colchicine use: known intolerance, previous use for another condition (e.g., gout), severe liver disease (e.g., severe liver disease).
• Severe liver disease (transaminase elevation 3 times above normal), blood dyscrasia (leukocyte or platelet count lower than normal), glomerular filtration rate (MDRD), use of CYP3A4 or calcineurin inhibitors, active autoimmune disease or the use of chronic anti-inflammatory therapy, concomitant infection, pregnancy or concomitant infection, pregnancy or lactation.
• Any other disease that limits life expectancy to \<1 year.
• Medical history of a disorder that could, in the opinion of the treating physician, place the participant at significant risk if they were to participate in the trial.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Fondo Nacional de Desarrollo Científico y Tecnológico, Chile: collaborator

Study Sites (1)

Hospital Clínico Pontificia Universidad Catolica de Chile

Santiago, Santiago Metropolitan, 8330024, Chile

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Gonzalo Martínez, MD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gonzalo Martínez, MD

CONTACT

56 223543218; gmartinezr@med.puc.cl

Maria Paz Orellana

CONTACT

011 56 979683630; mporella@uc.cl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective randomized comparison between colchicine versus no colchicine in terms of microvascular coronary reperfusion and infarct size in patients with acute coronary syndrome.

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: July 25, 2022
• Study Start: August 1, 2022
• Primary Completion: March 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)